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Job Description & How to Apply Below
Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
Draft and finalize controlled correspondences on complex issues.
Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
Review API and FP in-vitro characterization/sameness reports.
DMF review for complex APIs as per the workflow.
To collaborate and work closely with cross functional teams.
To meet the management expectations w.r.t timelines and quality.
To work closely within the team and provide training to new members on new regulatory requirements for Complex products.
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Search Our Career Opportunities - Amneal Pharmaceuticals
Position Requirements
10+ Years
work experience
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